{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Salt Lake City",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66949",
      "recalling_firm": "Integra LifeSciences Corp. d.b.a. Integra Pain Management",
      "address_1": "3498 West 2400 South #1050",
      "address_2": "N/A",
      "postal_code": "84119",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-0551-2014",
      "product_description": "Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.  Integra\u001e Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.",
      "product_quantity": "731",
      "reason_for_recall": "Integra LifeSciences is voluntarily recalling any  unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies.   kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.",
      "recall_initiation_date": "20131126",
      "center_classification_date": "20131220",
      "termination_date": "20140409",
      "report_date": "20140101",
      "code_info": "Lot No. W1302120    Expires 2/1/2014                Lot No. W1305038    Expires 8/1/2015                Lot No. W1306137    Expires 9/1/2014",
      "more_code_info": ""
    }
  ]
}